Tag: eHealth

Conference on telemedicine

On 4 October 2018, I was invited by Planète santé to speak at the assises de la médecine romande on the topic of telemedicine. The title of my conference was:

Telemedicine : legal framework for physicians

The Swiss health forum 2018, including the “assises de la médecine romande”, is global conference and Forum where more thatn 1’000 healthcare professionals and doctors meet and participate during a few days. This forum held a practical conference on the ‘digitalisation of the medical profession‘. I had the pleasure to speak along with Dr Jean-Gabriel Jeannot and other healthcare experts, including lawyers and physicians on digital in the context of healthcare.

Dr Jean-Gabriel Jeannot and I had the pleasure to develop thoughts and highlights challenges with this specialized audience in the context of telemedicine. For those who do not know him, Dr Jeannot is a Swiss physician specialized in internal medicine known for his digital initiatives to medical care, his numerous websites Medicalinfo, Medplus.ch, cabinetmedical.ch and his large amount of articles on his blog hosted by the local newspaper “Le Temps”. He spoke about the practical aspects of telemedicine for physicians, while I tackled the legal part of the topic. I mainly oriented my presentation for global awareness to healthcare professionals and doctors about legal issues which they may not find obvious, while offering practical recommendations.

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ISSUES RAISED BY TELEMEDICINE

Telemedicine is a wide topic.

Physicians and healthcare professionals have issued a few guidelines. Just to name a few, in the US, the American Telemedicine Association (ATA) and, in Europe, the Standing Committee of European Doctors (CPME) have created a useful documents, containing best practices for telemedicine services and remote healthcare.

Those guidelines are a first step to understand what a telemedicine project requires as a minimum. But a telemedicine project or initiative, may remain very simple (such as online or telephone medical consultations) or become extremely complex. Healthcare remains a heavily regulated environment, where laws are different in each country, with different practices and particularities, especially for cross-border projects. Moreover, there are many other aspects to take into consideration, such as from a regulatory perspective. Other issues relates to how securing contracts with third parties and partners in distant healthcare, how to tackle protection of health data and personal data under local laws, including the GDPR, as well as liability issues and how insurer can recognize distance medical services and reimburse them to  patient and pay doctors.

Structure of my conference

The main points of my talk related to three main pillars:

(1) Acts of telemedicine

The first part consisted in presenting the different acts of telemedicine that healthcare professionals my do. For each act, I have explained the typical contract that needs to be in place, highlighting the problem what issues may arise in each different scenario. A physician may provide four types or acts of telemedicine :

  • teleconsultations, which relate to the distant telephone or videoconferencing to provide a medical evaluation, including e-prescribing;
  • teleexpertise, where one physician instruct another physician that is answering remotely as an expert;
  • teleassistance, which applies in the event a doctor is unable to examine a patient on the site (emergency, distance, etc.) and a third person that is not a doctor assists the patient while communicating with the remote doctor based on his instructions; and
  • telesurveillance, which may involves remote biomonitoring of vital functions of the body, where a doctor is not present, or because there is no need for medical examination directly on the patient.

(2) Legal framework for physicians

The second part of my presentation was about the legal issues of telemedicine for doctors. It consisted in answering to a few questions, such as:

  • does telemedicine require a particular legal framework and how law applies to it?
  • who can practice telemedicine?
  • how to manage protection of health data?
  • telemedicine  and liability: how to minimize the risks?
  • how does the social insurance reimbursement work for telemedicine services?

(3) Recommendations

Finally, the last part had a main goal to provide practical guidelines and checklist for doctors and healthcare professionals, including insurance companies and innovators (start-ups and hospitals).

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TELEMEDICINE IS NOT A NEW METHOD, BUT A GROWING MARKET

A bit of history. It is not obvious to realize that the practice of medical services remotely is pretty ancient. The system of emergency medical hotline that associations of doctors have set up is a proof of it, as has been working for decades.

We can already find acts of telemedicine provided at the early 20th century.  Since the telephone invention in the late 19th, and television in early 20th century, doctors have provided medical services through different means, such as telephone (ECG and EEG), videoconferences in the context of psychiatry, virtual reality and with more modern tools after the invention of TCP/IP, etc. Four days before 9/11, the famous remote “Lindberg” surgery was a success, which demonstrated that technology could bring promising solutions remotely even to perform extremely sensitive acts of medicine.

In Switzerland, two main centers of telemedicine are in place since early 21st century, created by, and based on the model of, insurance companies such as Medgate and Medi24. These 2 providers mainly offer acts of teleconsultation (medical telephone calls). Other insurer now propose remote medical services, such the software myguide that the CSS insurance company provides to its clients.

Private initiatives, such as “heal-me” ” (“soignez-moi” in French) offer non-synchronized models (compared to synchronized). This online telemedicine platform allow patient to only pay CHF 39.- per consultation, with a assurance to receive a call from a doctor with a timeframe of 60 minutes. If the response takes longer, the medical consultation becomes free of charge, which becomes an incentive for the platform to ensure performance and availability for patients.

With respect to private clinics, the Aevis Victoria Group has massively invested telemedicine with acquisition of 40% of the share in MedGate, the Swiss leader in telemedicine. The Group also increased its participation in “LifeWatch AG” with an IPO in 2017. THis company is specialized in developing tools and devices for distant medicine. The Aevis Victoria Group continues to invest in other institutions or projects in the area.

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NOW WHAT?

Potential, but a probable slow growth. With such investments, and the potential of telemedicine, this market is likely to grow and complement ordinary medical care. One thing is sure, telemedicine will never replace ordinary physical examinations on patients. But it appears that physicians remain careful with distant medicine, probably for liability matters, or not knowing that most remote medical acts can be reimbursed by social insurances, by not using electronic communications, such as e-mail or text messages, or simply because they do not have the time or the need to change the way the provide healthcare to patient.

There are many ongoing initiatives, but as we saw, regulatory, legal, political barriers and reluctance from doctors. So this market remains full of potential, but is likely to grow slowly before becoming more in the daily practice and complement traditional care.

Some elements to consider. Patients use more electronic communication means. They have few time to go and visit the doctor. Nowadays, it is common that both parents work and struggle to organize to find medical appointments either for themselves or for their kids. They also prefer not to go to the doctor unless it becomes urgent. Sometimes, they even perform medical care on themselves. Now patients change their doctor more easily, or even have not a general physician: therefore telemedicine has all potential to match with a true market.

Now the players arriving with new ideas on the market will have to demonstrate that it is worth it from an economical and quality standpoint, while being able to reduce the costs of healthcare.

But maybe, digital medical office are not so far to come on the market…

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To know more:

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You are launching a project in the context of digital health or distant healthcare? If you have questions or want to meet, go and check out our platform and schedule a meeting with us on datalex.

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Abilify connected pill: ethics and privacy aspects of Personal Health Monitoring

ABILIFY MYCITE: A FIRST FDA APPROVAL FOR mHEALTH AND CONNECTED MEDICAL DEVICES

On 13 November 2017, we have probably reached a historical new step in digital health (and mHealth) with this market approval from the FDA for “Abilify MyCite“, the first digital tracking-pill which sends data to your doctor. This connected pill is used to track whether patients sufferring from schizophrenia, bipolar I disorder, and depression have taken their medication, which is used for Personal Health Monitoring (‘PHM‘).

As mentionned by Pharmacytimes:

“the approval of the pill and the sensor together represents a first for the FDA“

even if the sensor itself that is used along with aripiprazole (substance used for patient suffering from schizophrenia) was first cleared for use by the FDA in 2012. As secondary or side effects, the clinical trials revealed adverse events such as nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. However, the common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.

Find more information on the website of the FDA.

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TECHNOLOGY AND FUNCTIONALITIES – How it works

On the technology side, the sensor embedded into the Ability MyCite pill syncs with a smartphone and sends an alert to the patient’s smartphone. The doctor receives also a notification through the App when the medication is ingested via a patch that is worn on the surface of the skin of the patient. If the patient shares its data with his practitioner, the latter has the ability to monitor whether the patient has ingested properly. According to the US TV channel PBS, researchers are also trying to manufacture ePills that collect and process other body-related data by monitoring internal heat of the body for several days long.

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TECHNICAL ASPECTS OF THE DEVICE

According to LiveScience, the technical aspects are as follows:

“It’s a partial power source, “the patient becomes the battery”. The pill integrates a silicon chip with a logic circuit and contains copper and magnesium.  The chip’s logic circuit makes a small modulated current — a graph of the current levels would look like a sine wave. Since the human body is conductive, the wearable sensor can pick up the changes. The modulated current can encode ones and zeroes, similar to an FM signal. “It works in a similar way as an EKG,” or electrocardiogram. These machines pick up on changes in electrical current in the body to monitor heartbeats. The wearable sensor does the same thing, though the current is smaller.” The pill is designed to work for only about 3 minutes. That’s just enough time for it to send a signal to the wearable sensor that it should wake up and start gathering data. That saves battery power and allows the wearable sensor to work for a week at a time.

The patch and sensor is manufactured by the company Proteus Digital Health and aripiprazole marketed by Otsuka Pharmaceutical.

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ETHICS AND LEGAL ISSUES

PATIENT MONITORING AND REDUCING HEALTH COSTS

Personal Health Monitoring (‘PHM ‘) contains at least two major advantages.

MEDICAL COMPLIANCE – being the “consistency and accuracy with which someone follows the regimen prescribed by a physician or other health professional“. In the context of mental disability, the physician must ensure that the patient suffering from a mental disorder takes the prescribed medication on a regular basis. This may be particularly interesting for patients who may find themselves incapable of making a proper judgement (such as elder people). In the USA, a study from the National center for biotechnology information showed that “an estimated 50% of those who respond well to medications are nonadherent to their treatment regime“. Therefore, medical compliance is also a important challenge for patients who are suffering from a mental illness; and

HEALTHCARE COSTS – which could be reduced if more patients would take their pill properly. Consequences are both medical and financial. When a patient do not or, forgets to, take a pill, or do not follow the treatment as prescribed, his/her health may be worsened and this person may require treatment adjustment, more medicine, another hospitalisation or even a further surgery should there be a need to. In particular, this article indicates that the “loss that the taxpayer incurs when patients fail to take their medication, the cost of which is assumed to be at least $100 billion. According to an American report, these numbers could even be between $100 et $300 billion.

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TECHNOLOGICAL ADVANCEMENT: YES.  BUT AT WHAT COST AND
TO WHAT EXTENT DOES THIS REMAIN A PROGRESS?

Although such technological advancement (connected pill to track patient’s medical compliance) is remarkable for healthcare costs reduction, not everybody agrees to it, especially within the medical profession. Moreover, it is legitimate to ask to what extent such technology can constitute a practical improvement, not just a scientific progress.

What value does this progress add for patients, the healthcare system and the society in general? What does it improve, is it better than before? If yes, how and what are the bad sides of it? What is the balance between the bad and good sides of this? Will the benefits for the patient override financial benefits?

Some people already rose their voice and expressed reluctance to Personal Health Monitoring (‘PHM’), which scientists have already looked into and published on this complex topic. (see additional notes on that topic at the end of this article).

Altough a few have called this practice “medical Big Brother (or biomedical Big Brother according to the New York Times), PHM raises a number of ethical questions, which can lead to at least 8 key  points and interrogations:

1. Privacy – for personal health monitoring, two types of privacy aspects can emerge, which are personal privacy and data privacy. This also relates to risk of interference in the private life of the patient by collecting and processing health (sensitive or even biometric) patient data. Is such data processing in compliance with explicit consent of the patient, who may not able to make a proper judgement?  This article describes very well some privacy aspects  that personal health monitoring are raising.

2. Visibility or  obstrusiveness – Visibility appears to refer to “the degree to which a PHM device is noticeable by the user and other individuals, both at home and in public“. In accepting the use of tracking devices for dementia patients, cognitively intact older adults identified ease of use, size and weight as important in accepting a tracking technology. One consider the patient differently, being seen as an ill human being. This may create a risk of discrimination by the society and the person might be more vulnerable;

3. (over)Medicalization – the devices have the effect of reminding the user or occupants of a medical condition in a non-medical environment. The home could be turned into a medical environment or “de facto intensive care unit” as well as creating stigmatization linked to the fact that the person feels under surveillance;

4. Social isolation – the patient monitored will reduce or cease going to the hospital or to see the physician for regular check-ups. Therefore, this could increase patient’s loneliness and social isolation with psychological and medical consequences with a lack of motivation and reduction of the mentality;

5. Autonomy – what room remains to the patient with PHM to decide how to take the pill or not? What if the patient wishes to stop taking the pill, for good reasons? Where are we talking about pressure on the patient will?

6. Shame et identity – what consequences could there be on the personality of the patient, who may be perceived by the society as marginal human being, in particular when the treatment is visible?

7. Providing healthcare – with remote care, to what extent does this improve or reduce its effectiveness, especially when the patient does not move him/herself anymore? Is this an efficient manner to treat a patient, shall this remain the exclusive way of doing it or should we combine it with physical appointments?

8. Security and reliability of the technology. This element is obviously central for both privacy and health reasons.

Do these aspects reduce or delete the patient’s responsibility or does it create an over-responsibility? With or without benefits?

How about from an insurance point of view if the patient do not takes the pill while he/she is being monitored with or without worsening of his/her health? Suspension, reduction, cessation of the payment by the insurance or the medical measures? To what extent can the insurance have access to such information or personal health-related data?

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A PRIVACY PERSPECTIVE?

As this article pointed out, despite huge costs reductions (around 100 billion) and health benefits of this mHealth technology for the healthcare system and patients, patient’s privacy is an area of concern which is even more related to medtech technologies with Big data and IoT (Internet of Things) in the healthcare sector. Combined with the patch worn by the patient, the sensors that are embedded into the pill may provide far more data about the patient than just taking a pill or not.  The device may be used in a way to gather data from the patient’s body, such as the heart rate, how much the patient sleeps, how fit the patient is, etc.

The major concern is the misuse of such sensitive data, which could be used by corporations or government to collect more personal and biometric information about citizens that they had consented to revealing. Furthermore, since the technology has only recently come into the public domain, very few regulations exist to police it, says this article. Misuse for marketing purposes, is one thing. Data breach, criminal intents, or cyberattack on the device itself are another thing with severe consequences for both patients’ health, privacy and reputations of tech and pharma organizations. Further, another study explains that it appears impossible to obtain informed consent from recipients of PHM because full understanding of the implications of using PHM cannot be gained without actually using the technology. Therefore, using the technology without informed consent, may be considered as illegal processing, which creates a vicious circle. This article suggests that piloting methods such as storytelling and prototyping may present a possible solution to this problem and avoid collecting personal data without the proper legal basis for processing.

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PRIVACY AND INFORMATION SECURITY 

From an EU and Swiss perspective, health-related data (health or biometric) is considered as a special category of personal data that we call “sensitive data“, where the processing is generally prohibited, unless the controller can demonstrate a legal ground for the processing, such as the patient’s explicit consent (art. 9 §2 (a) GDPR, art. 4 al. 5 and 13 al. 1 of the Swiss DPA), the provision of medical services by a health professional tied by a secrecy obligation (art. 9 §2 (h) and 9 §3 of the GDPR) or private overriding interests (art. 13 al. 2 of the Swiss DPA). As one can read in the press almost everyday now, cyberattacks can happen, and a data breach may lead authorities to impose hefty fines, with 4% of worldwide annual turnover according to article 83 of the GDPR, although fines should remain a last resort in the sanction mechanism applied by the authorities. I wrote a note in this article about the envisaged approach with fines and sanction pursuant to the GDPR.

In addition, the doctor would also have to require the patient’s prior explicit consent before sharing, or allowing any third party to access, any sensitive data . See my previous note on recommendations for outsourcing in the context of medical billing for healthcare professionnals.

There are many other obligations under these regulations, which this article does not intend to cover.

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CONCLUSION

This FDA approval sounds like a very good “signal” to pharmaceutical companies developing connected drugs and advanced digital life science technologies, mHealth and medical devices.  This can improve the life of many patients, while saving costs and improving efficiencies in the treatment.

There is no need for scaremongering. However, remaining careful using the device for the purpose of the treatment, informing the patient and gathering explicit consent, processing only the data that is necessary for the purpose of the treatment, working with ethics and respect for the individual, especially if these patients have a reduced of discernment, are some good steps to ensure the individual’s privacy.

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To read more on this topic:

  • Mittelstadt, Brent, Ben Fairweather, Mark Shaw and Neil McBride. “The Ethical Implications of Personal Health Monitoring.” IJT 5.2 (2014): 37-60.Web.4Feb.2018.doi:10.4018/ijt.2014070104.
  • Mittelstadt, B., Fairweather, N.B., McBride, N., Shaw, M., 2011. Ethical Issues of Personal Health Monitoring: A Literature Review, in: ETHICOMP 2011 Conference Proceedings, ETHICOMP 2011, Sheffield, UK.
  • Elin Palm, Anders Nordgren, Marcel Verweij and Göran Collste, Ethically Sound Technology? Guidelines for Interactive Ethical Assessment of Personal Health Monitoring, 2013, Interdisciplinary Assessment of Personal Health Monitoring, 105-114.
  • Nordgren, Anders. (2013). Privacy by Design in Personal Health Monitoring. Health care analysis : HCA : journal of health philosophy and policy. 23. . 10.1007/s10728-013-0262-3.
  • Data protection and privacy in connected health, an article from a blog for research and innovation relating to emerging technologies.
  • Information notice  from “Otsuka Pharmaceutical”, the manufacturer of Abilify Mycite.

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By Gabriel Avigdor | NTIC.ch